API 20 E 25STRIPS
Received Aug 10, 2021
Report 9615754-2021-00224 · MDR key 12301728
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION IN RESPONSE TO A CUSTOMER COMPLAINT OF THE MISIDENTIFICATION OF ESCHERICHIA COLI AND PSEUDOMONAS AERUGINOSA AS SALMONELLA IN ASSOCIATION WITH THE API® 20 E TEST STRIP (REF. 20100, LOT 1008123340) WHEN PERFORMING A COMPARISON STUDY. THE CUSTOMER STATED THAT THE IMPACTED STRAINS WERE NOT AVAILABLE TO SUBMIT FOR INVESTIGATION. REVIEW OF LOT 1008123340 PRODUCTION RECORDS FOUND THAT NO NON-CONFORMITY WAS RECORDED. BIOMÉRIEUX REVIEWED COMPLAINTS FOR MISIDENTIFICATIONS ASSOCIATED WITH REF. 20100 AND FOR COMPLAINTS ASSOCIATED WITH LOT 1008123340; NEITHER REVIEW IDENTIFIED A TREND. A STUDY WAS PERFORMED BY USING THE KNOWLEDGE BASE (KB) API 20 E TO COMPARE THE RESULTS THE CUSTOMER OBTAINED WITH THE PERCENTAGE OF THE TESTS IN THE KB FOR ESCHERICHIA COLI AND PSEUDOMONAS AERUGINOSA. THE RESULTS OF THE STUDY OF BIOCHEMICAL PROFILES INDICATE THAT THE PROFILE OBTAINED WAS NOT RELATED TO A MIXTURE OF ESCHERICHIA COLI AND PSEUDOMONAS AERUGINOSA STRAINS INCLUDED IN THE SAMPLE. THE INVESTIGATION IDENTIFIED POTENTIAL CAUSES OF THE MISIDENTIFICATION WERE: - A CONTAMINATION OF THE SUSPENSION BY ANOTHER STRAIN, - AN ERROR DURING THE REALIZATION OF THE SUSPENSION BY USING ANOTHER STRAIN TO INOCULATE THE STRIP, - THE COLONY IDENTIFIED WAS A SALMONELLA SPP.
Description of Event or Problem
INTENDED USE: API® 20 E IS A QUALITATIVE STANDARDIZED SYSTEM FOR THE IDENTIFICATION OF ENTEROBACTERIACEAE AND OTHER NON-FASTIDIOUS GRAM-NEGATIVE RODS. IT USES MINIATURIZED TESTS AS WELL AS A SPECIALLY ADAPTED DATABASE. INOCULATION AND READING OF THE STRIP ARE PERFORMED MANUALLY AND THE IDENTIFICATION IS OBTAINED USING AN IDENTIFICATION SOFTWARE. DESCRIPTION OF THE ISSUE. A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING AN IDENTIFICATION OF SALMONELLA WHILE THE TESTED SAMPLE WAS "SIMULATED 10G CARCASS ¿ ESCHERICHIA COLI + PSEUDOMONAS AERUGINOSA" DURING EXTERNAL QUALITY CONTROL TEST USING THE PRODUCT API 20 E (REF 20100, LOT#1008123340). A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.